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Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate
Telix seeks FDA approval for TLX101-Px, a PET imaging agent with orphan drug and fast track status, to improve glioma diagnosis in adults and children.
- On March 16, 2026 Telix resubmitted a New Drug Application to the U.S. FDA for TLX101-Px, including additional data following a Type A meeting.
- Telix noted TLX101-Px holds Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration, with international guidelines including 18F-FET PET for glioma imaging, though no FDA-approved targeted amino acid PET agent is available in the U.S.
- TLX101-Px targets LAT1 and LAT2 membrane transporters, enabling its use as a companion diagnostic to TLX101-Tx, Telix's therapy candidate studied in the IPAX-BrIGHT pivotal trial.
- Patients face limited approved imaging options, as GBM affects roughly 22,000 new U.S. cases annually with recurrence common and survival expected 11-15 months from diagnosis, with no marketing authorizations for TLX101-Px or TLX101-Tx.
- Advocacy groups welcomed FDA engagement, with Maggie Haynes saying, 'Our community is encouraged by the FDA's ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px,' supported by an extensive and compelling data set.
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Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate - Telix Pharmaceuticals (NASDAQ:TLX)
MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces the resubmission of a New Drug Application (NDA) to the United
·New York, United States
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Telix (ASX:TLX) Pixclara NDA Resubmitted, The FDA Clock Restarts
Pixclara Back With the FDA Telix has resubmitted its NDA to the FDA for Pixclala, its PET imaging agent for recurrent or progressive glioma, a common type of brain tumour. Pixclara is a targeted amino acid PET scan designed to help distinguish true tumour recurrence from treatment-related changes in adult patients. That is a real…
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